Botulinum Toxin for Stomach Cancer Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by St. Olavs Hospital
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01822210
First received: March 21, 2013
Last updated: April 30, 2015
Last verified: April 2015
  Purpose

Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.


Condition Intervention Phase
Stomach Neoplasms
Drug: Botox
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Change of tumor volume in the stomach. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).

  • Change of tumor volume in the stomach. [ Time Frame: 8 weeks and 20 weeks ] [ Designated as safety issue: No ]
    Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  • Toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  • performance status [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    ECOG scale

  • performance status [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    ECOG scale

  • performance status [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
    ECOG scale


Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox
Injection of Botox in the tumor and surrounding stomach wall.
Drug: Botox
injection by gastroscopy (100 Allergen units)
Other Name: Botulinum toxin

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with verified gastric adenocarcinoma but found non-resectable or inoperable after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim University Hospital. The inclusion criteria for such patients are:

  1. Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.
  2. Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.
  3. Patients who, after meticulous information about chemotherapy, still do not want such treatment.
  4. Patients with performance status (ECOG) 0-2.

Exclusion criteria:

  1. Known allergy to any of the components in Botox®
  2. Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular transmission (for example: Myasthenia Gravis or Eaton-Lambert`s Syndrome).
  3. Pregnant or lactating women.
  4. Another cancer disease that is not under control.
  5. Another concomitant treatment for cancer.
  6. Serious mental illness.
  7. Performance status (ECOG) 3-4.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822210

Contacts
Contact: Jon Erik Grønbech, MD, PhD jon.e.gronbech@ntnu.no
Contact: Gøran T Andersen, MD goran.t.andersen@ntnu.no

Locations
Norway
Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital Recruiting
Trondheim, Norway
Contact: Jon Erik Grønbech, MD PhD       jon.e.gronbech@ntnu.no   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Jon Erik Grønbech, MD. PhD. St. Olavs Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01822210     History of Changes
Other Study ID Numbers: StOlav2205, 2012-002493-31
Study First Received: March 21, 2013
Last Updated: April 30, 2015
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by St. Olavs Hospital:
Botulinum Toxins
Injections
Stomach
Tomography, X-Ray Computed

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015